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Research Notes
Self-sealing capacity of vial stoppers after multiple needle punctures
James A. Ponto, MS, BCNP, FAPhA
J Am Pharm Assoc (2003) 2013;53:58-60. doi:10.1331/JAPhA.2013.12064

Abstract

Objective  To evaluate the self-sealing capacity of vial stoppers in two common radiopharmaceuticals after more than 10 needle punctures.

Methods  Assessment of self-sealing capacity was performed according to the self-sealing capacity test described in United States Pharmacopeial Convention (USP) General Chapter <381>. Groups of 10 vials of technetium (Tc)-99m sulfur colloid and Tc-99m tetrofosmin were tested for maintenance of self-sealing capacity following 10 punctures with 22-, 20-, and 18-gauge needles. Each vial was sequentially retested after additional sets of 10 punctures until failure of self-sealing capacity or until a total of 100 punctures, whichever came first.

Results  The median number of needle punctures with maintenance of self-sealing ability before failure for 22-, 20-, and 18-gauge needles was >100 (range all >100), >100 (all >100), and 60 (30–90), respectively, for sulfur colloid and >100 (all >100), >100 (50 to >100), and 50 (20–70), respectively, for tetrofosmin. Incidentally, coring particles were observed frequently in vials after many punctures with 18-gauge needles, but infrequently with 20-gauge and rarely with 22-gauge needles.

Conclusion  Vial stoppers in two radiopharmaceutical products demonstrated robust self-sealing capacity, substantially exceeding the USP standard of 10 punctures with a 21-gauge needle. Coring particles were frequently observed after many punctures when using larger-bore needles but rarely when using smaller-bore needles. Under conditions commonly used, failure of self-sealing capacity and generation of coring particles are not anticipated to be problems encountered when puncturing vial stoppers of these two products substantially more than 10 times.

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References

United States Pharmacopeial Convention. <381> Elastomeric closures for injections. USP 34–NF 29. Rockville, MD:  United States Pharmacopeial Convention;  2011.
 
GE Healthcare. Myoview kit for the preparation of technetium Tc99m tetrofosmin for injection. Arlington Heights, IL:  GE Healthcare;  2006.
 
 Pharmalucence. Kit for the preparation of technetium Tc99m sulfur colloid injection. Bedford, MA:  Pharmalucence;  2008.
 
United States Pharmacopeial Convention. <1> Injections. USP 34–NF 29. Rockville, MD:  United States Pharmacopeial Convention;  2011.
 
Chanana GD, Guo X, Avis KE, et al. Evaluation of closure integrity after multiple penetrations. J Parenter Sci Technol. 1993; 47( 47): 22– 5.
 
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